JB Chemicals and Pharmaceuticals recalls Enalapril Maleate Tablets, USP, 20 mg over failed impurity test
A test of the 1,000-count bottles of Enalapril Maleate Tablets, USP, 20 mg gave an out of specification result for organic impurities, so they failed the impurities and degradation specifications.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
- Hazard
- Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- Units
- 675 bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- May 5, 2026
- Recall started
- April 23, 2026
- FDA enforcement report
- May 13, 2026
- Identifiers
- Codes: Lot #: GEH25023, Expires: 6/30/2027
- FDA recall number: D-0520-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 675 bottles
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